An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure

PHASE3CompletedINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

November 30, 2012

Study Completion Date

February 28, 2013

Conditions
Reversal of Coagulopathy
Interventions
BIOLOGICAL

Beriplex® P/N (Kcentra)

Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.

BIOLOGICAL

Fresh frozen plasma

Intravenous infusion, dosage depending on baseline INR and body weight

Trial Locations (30)

652

Study Site, Saida

1606

Study Site 4, Sofia

7002

Study Site, Rousse

9010

Study Site, Varna

14642

Study Site, Rochester

18711

Study Site, Wilkes-Barre

19107

Study Site, Philadelphia

19611

Study Site, West Reading

19718

Study Site, Newark

27157

Study Site, Winston-Salem

38163

Study Site, Memphis

40536

Study site, Lexington

55415

Study Site, Minneapolis

55805

Study Site, Duluth

77030

Study Site, Houston

77802

Study site, Bryan

78701

Study Site, Austin

79905

Study Site, El Paso

87131

Study Site, Albuquerque

105203

Study Site 1, Moscow

125206

Study Site 2, Moscow

192242

Study Site, Saint Petersburg

300736

Study Site, Timișoara

420012

Study Site, Kazan'

630051

Study Site, Novosibirsk

656038

Study Site 2, Barnaul

02114

Study Site, Boston

Unknown

Study Site 1, Minsk

Study Site 2, Minsk

2833-7401

Study Site, Beirut

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY